Evaluation of the Post-vaccination Immune Response to COVID-19 in the New Caledonian Population

NCT05135585 | Completed

• 2 other identifiers: 2021-0592021-A01949-32
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 3

Brief Summary

The COVID-19 pandemic caused by SARS-CoV-2 since December 2019 has caused more than 210 million cases worldwide as of September 1, 2021. New Caledonia (NC) is an ultramarine French territory in the South Pacific so far relatively spared by this pandemic thanks to the establishment of a health lock. The vaccination campaign started locally on 20/01/2021 with the exclusive use of Pfizer's COMIRNATY mRNA vaccine. Vaccination is now offered to anyone over the age of 12. Vaccination against COVID-19 will be mandatory in New Caledonia as of October 31, 2021 for certain exposed populations and for the entire adult population as of December 31, 2021. Clinical trials of COVID-19 vaccines, including those of mRNA vaccines, have taken care to maintain ethnic diversity within their samples. Efficacy studies have not shown a significant difference in the efficacy of Pfizer COMIRNATY vaccine in white, black American, or Hispanic populations. The response of non-European non-Asian Oceanian populations to Pfizer COMIRNATY vaccination has not been specifically studied at this time. According to the 2019 census in New Caledonia, 41.2% of the population identified themselves as Kanak (Melanesian), 24% as European, 8.3% as Wallisian-Futunian (Polynesian), 11% as mestizo, and 8% as belonging to other communities including Tahitian (Polynesian), Indonesian, Ni-Vanuatu (Melanesian), and Vietnamese communities (8). Some recent data are in favor of a significant variability of susceptibility to pathogens in Oceanian populations, stemming from a genetic inheritance from Neanderthal man and his cousin Denisova man. In a context of vaccine hesitancy, it is therefore important to ensure that the immune response of the New Caledonian population (Melanesian, Polynesian, European or other communities) to vaccination against COVID-19 is similar to that of populations studied in large clinical trials.

Conditions

SARS-CoV-2 Acute Respiratory Disease

Keywords

Immune Response; Vaccination; Pacific; Population of New Caledonia

Outcome Measures

Primary Outcomes (1)

• Measurement by ELISA tests of the presence of antibodies at 1 month after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population

  To assess in a standardized manner the humoral immune response to COVID-19 vaccination at 1 month after the second dose in vaccinated individuals of Polynesian, Melanesian, European and other communities in New Caledonia

  6 months

Secondary Outcomes (3)

• Measurement by ELISA of the presence of antibodies at 6 months after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population

  1 year

• Serum neutralization analysis of the neutralizing capacity against different circulating SARS-CoV-2 variants of antibodies secreted at 1 and 6 months after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population

  1 year

• Post-hoc analysis of anti-Spike and anti-Nucleoprotein ELISA results at 1 month by age stratification (group over 70 years and control group 20-59 years)

  1 year

Study Arms (1)

Adults vaccinated with a complete COVID-19 vaccine regimen

OTHER

Adults of Melanesian, Polynesian, European, and other communities vaccinated with a complete COVID-19 vaccine regimen, residing in New Caledonia.

Other: Blood sample collection; Other: Questionnaires

Interventions

Blood sample collection OTHER

Blood sample collection at 1 month and 6 months after vaccination

Adults vaccinated with a complete COVID-19 vaccine regimen

Questionnaires OTHER

data collection (health data, vaccination data, etc.)

Adults vaccinated with a complete COVID-19 vaccine regimen

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults from Melanesian, Polynesian, European or other community origin
• Adults vaccinated with 2 doses of Pfizer COMIRNATY vaccine, administered between 3 and 12 weeks apart
• Adults planning to be present in the territory and to be available on both sampling dates (1 and 6 months)

You may not qualify if:

• Persons who received the second dose of vaccine more than 12 weeks after the first dose
• Persons vaccinated against COVID-19 with a vaccine other than Pfizer COMIRNATY
• Women who report being pregnant or breastfeeding (where the immune response may be altered)
• Immunocompromised persons (immunosuppressive treatment, immunomodulator, HIV positive, splenectomy, long term corticosteroid therapy, autoimmune diseases such as rheumatoid arthritis, lupus, spondyloarthritis, etc.)
• People who are not intellectually capable of answering the questionnaire
• Persons under guardianship, curatorship or any other legal incapacity

Sponsors & Collaborators

• Institut Pasteur: lead
• Centre Hospitalier Spécialisé de Nouvelle-Calédonie: collaborator
• Direction de l'Action Sanitaire et Sociale: collaborator
• Centre Hospitalier Territorial de Nouvelle-Calédonie: collaborator
• Agence sanitaire et sociale de la Nouvelle Calédonie: collaborator

Study Sites (3)

Centre Hospitalier Territorial de Nouvelle-Calédonie

Dumbéa Sur Mer, New Caledonia

Location

Centre hospitalier spécialisé de Nouvelle-Calédonie

Noumea, New Caledonia

Location

Vaccination centers

Province Sud, New Caledonia

Location

Related Publications (1)

• Inizan C, Courtot A, Sturmach C, Griffon AF, Biron A, Bruel T, Enouf V, Demaneuf T, Munier S, Schwartz O, Gourinat AC, Medevielle G, Jouan M, van der Werf S, Madec Y, Albert-Dunais V, Dupont-Rouzeyrol M. Levels and functionality of Pacific Islanders' hybrid humoral immune response to BNT162b2 vaccination and delta/omicron infection: A cohort study in New Caledonia. PLoS Med. 2024 Sep 26;21(9):e1004397. doi: 10.1371/journal.pmed.1004397. eCollection 2024 Sep.

  PMID: 39325828 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Myrielle Dupont-Rouzeyrol, PhD

  Institut Pasteur de Nouvelle-Calédonie

  STUDY DIRECTOR

• Valérie Albert-Dunais, MD

  Centre Hospitalier Spécialisé de Nouvelle-Calédonie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: November 26, 2021
• Study Start: December 1, 2021
• Primary Completion: September 17, 2022
• Study Completion: September 17, 2022
• Last Updated: November 9, 2022

Record last verified: 2021-10

Locations

NE (3)